Department of Cancer Medicine, Institut Gustave Roussy, Villejuif
Department of Biostatistics, Centre Léon Bérard, Lyon.
Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.
Bevacizumab combined with paclitaxel as first-line chemotherapy for patients with HER2-negative metastatic breast cancer (MBC) has led to mixed results in randomized trials, with an improvement in progression-free survival (PFS) but no statistically significant overall survival (OS) benefit. Real-life data could help in assessing the value of this combination.
This study aimed to describe the outcome following first-line paclitaxel with or without bevacizumab in the French Epidemiological Strategy and Medical Economics (ESME) database of MBC patients, established in 2014 by Unicancer. The primary and secondary end points were OS and PFS, respectively.
From 2008 to 2013, 14 014 MBC patient files were identified, including 10 605 patients with a HER2-negative status. Of these, 3426 received paclitaxel and bevacizumab (2127) or paclitaxel (1299) as first-line chemotherapy. OS adjusted for major prognostic factors was significantly longer in the paclitaxel and bevacizumab group compared with paclitaxel [hazard ratio (HR) 0.672, 95% confidence interval (CI) 0.601-0.752; median survival time 27.7 versus 19.8 months]. Results were consistent in all supportive analyses (using a propensity score for adjustment and as a matching factor for nested case-control analyses) and sensitivity analyses. Similar results were observed for the adjusted PFS, favoring the combination (HR 0.739, 95% CI 0.672-0.813; 8.1 versus 6.4 months).
In this large-scale, real-life setting, patients with HER2-negative MBC who received paclitaxel plus bevacizumab as first-line chemotherapy had a significantly better OS and PFS than those receiving paclitaxel. Despite robust methodology, real-life data are exposed to important potential biases, and therefore, results need to be treated with caution. Our data cannot therefore support extension of current use of bevacizumab in MBC.
贝伐珠单抗联合紫杉醇作为曲妥珠单抗阴性转移性乳腺癌（MBC）患者的一线化疗方案，在随机试验中的结果喜忧参半，虽然无统计学意义的总生存（OS）获益，但改善了无进展生存（PFS）。真实世界的数据可能有助于评估这种联合的价值。
本研究旨在描述法国癌症中心联盟（Unicancer）于 2014 年建立的法国 ESMES 数据库中，MBC 患者一线接受紫杉醇联合或不联合贝伐珠单抗治疗的结局。主要和次要终点分别为 OS 和 PFS。
2008 年至 2013 年，共纳入 14014 例 MBC 患者的病历，其中 10605 例患者 HER2 阴性。这些患者中，3426 例接受了一线化疗，其中紫杉醇联合贝伐珠单抗（2127 例）或紫杉醇（1299 例）。多因素调整后，紫杉醇联合贝伐珠单抗组的 OS 明显长于紫杉醇组[风险比（HR）0.672，95%置信区间（CI）0.601-0.752；中位生存时间 27.7 个月对 19.8 个月]。所有支持性分析（使用倾向评分调整和嵌套病例对照分析的匹配因素）和敏感性分析的结果一致。调整后的 PFS 也有利于联合治疗（HR 0.739，95%CI 0.672-0.813；8.1 个月对 6.4 个月）。
在这项大规模的真实世界研究中，HER2 阴性 MBC 患者一线接受紫杉醇联合贝伐珠单抗化疗的 OS 和 PFS 明显优于接受紫杉醇单药治疗的患者。尽管方法学稳健，但真实世界数据易受到重要的潜在偏倚影响，因此结果需谨慎对待。我们的数据不能支持当前在 MBC 中扩大贝伐珠单抗的使用。
